K061379 · Draeger Medical Systems, Inc. · MHX · Feb 16, 2007 · Cardiovascular
Device Facts
Record ID
K061379
Device Name
INFINITY TELESMART TELEMETRY SYSTEM
Applicant
Draeger Medical Systems, Inc.
Product Code
MHX · Cardiovascular
Decision Date
Feb 16, 2007
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 870.1025
Device Class
Class 2
Indications for Use
The INFINITY TeleSmart is a patient-worn transceiver (PWT) that is derived from miniaturization of the INFINITY ALPHA patient monitor. This new device performs telemetry monitoring of ambulatory and non-ambulatory patients, using the same algorithms that are incorporated in the INFINITY ALPHA.
Device Story
Patient-worn transceiver (PWT) for ambulatory/non-ambulatory telemetry monitoring; miniaturized version of Infinity Alpha monitor. Inputs: physiological signals (ECG, SpO2, pulse rate). Processing: utilizes same algorithms as Infinity Alpha for arrhythmia and ST segment detection. Output: physiological data and alarms transmitted to central monitoring station. Used in clinical settings; operated by healthcare professionals. Benefits: enables continuous patient monitoring while allowing mobility.
Clinical Evidence
No clinical data generated for this submission; equivalence established via non-clinical performance data and comparison to predicate devices.
Technological Characteristics
Patient-worn transceiver (PWT); miniaturized form factor; utilizes same algorithms as Infinity Alpha; wireless physiological signal transmission; Class II device.
Indications for Use
Indicated for ambulatory and non-ambulatory patients requiring physiological telemetry monitoring, including arrhythmia detection, ST segment monitoring, pulse oximetry, and pulse rate monitoring.
Regulatory Classification
Identification
The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.
Special Controls
*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
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510(k) SUMMARY as required per 807.92(c)
1. Submitter's Name and Address:
Draeger Medical Systems, Inc. 6 Tech Drive Andover, MA 01810
FEB 1 6 2007
Charles C. Morganson, Jr., Manager Regulatory Affairs Tel: (978) 379-8309 Fax: (978) 379-8333
Date submission was prepared:
Contact Person:
May 17, 2006
2. Trade Name, Common Name and Classification Name:
A. Trade Name:
Infinity TeleSmart Telemetry System
B. Common Name, Classification Name, Class and Regulation Number:
| Common Name | Classification Number | Class | Regulation Number |
|---------------------------------------------------------------------------|-----------------------|-------|-------------------|
| Detector and Alarm | 74DSI | II | 21 CFR 870.1025 |
| Monitor, Physiological,<br>Patient (with Arrhythmia<br>Detector or Alarms | 74MHX | II | 21 CFR 870.1025 |
| Cardiac Monitor | 74DRT | II | 21 CFR 870.2300 |
| ST Segment Monitor with<br>Alarm | 74MLD | II | 21 CFR 870.1025 |
| Pulse Oximeter | 74DQA | II | 21 CFR 870.2700 |
| Pulse Rate Monitor | 74BWS | II | 21 CFR 870.2300 |
| System, Network and<br>Communication,<br>Physiological Monitors | 74MSX | II | 21 CFR 870.2300 |
| Radiofrequency Physiological<br>Signal Transmitter and<br>Receiver | 74DRG | II | 21 CFR 870.2910 |
3. Predicate Device Identification:
Infinity MultiView Workstation Telemetry K024108
K051658 Infinity Alpha
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## 4. Device Description:
The INFINITY TeleSmart is a patient-worn transceiver (PWT) that is derived from miniaturization of the INFINITY ALPHA patient monitor. This new device performs telemetry monitoring of ambulatory and non-ambulatory patients, using the same algorithms that are incorporated in the INFINITY ALPHA.
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5. Comparison to Predicate Device:
The Infinity TeleSmart Telemetry System is substantially equivalent to the Infinity MultiView Workstation Telemetry cleared for market under 510(k) K024108 and Infinity Alpha, 510(k) K051658.
6. Assessment of non-clinical performance data for equivalence:
Refer to section 10
7. Assessment of clinical performance data for equivalence:
Was not generated for this submission
8 Biocompatibility:
Not applicable
9.Sterilization:
Not applicable
10. Standards and Guidance's:
Refer to section 10
